NCT07322042 · Poisera, Inc.
Evaluating Screening Adherence Between Moment for Parents App and Attention Control
What this study is about
Mental health challenges, such as depression and anxiety, are the most common medical complications during pregnancy and after childbirth. Many women experience these symptoms, yet half are never screened, let alone diagnosed. When mental health concerns go unnoticed, they can affect a mother's well-being, her birth experience, and her child's development.
View original scientific description
Mental health challenges, such as depression and anxiety, are the most common medical complications during pregnancy and after childbirth. Many women experience these symptoms, yet half are never screened, let alone diagnosed. When mental health concerns go unnoticed, they can affect a mother's well-being, her birth experience, and her child's development. When identified early, these conditions are treatable. However, current healthcare practices often fail to screen women consistently, and many women do not feel comfortable discussing emotional struggles with healthcare providers. This study will test whether a mobile app called Moment for Parents can help pregnant and postpartum women complete mental health screenings more regularly. The app includes educational articles, guided reflections, and mood check-ins that help women explore their feelings in a private, supportive environment. The app also includes a chatbot that guides them through short lessons about motherhood, stress, relationships, and emotional well-being. These conversations are designed to feel friendly and relatable, like talking with a knowledgeable companion rather than filling out a medical form. The investigators expect that this more personal experience may make it easier for women to notice and track changes in their mental health and encourage them to complete regular screeners. The study will enroll 160 women who are pregnant or within the first year after giving birth. Participants will be randomly assigned to one of two groups: Intervention group: Uses the full Moment for Parents app, including the interactive chatbot. Control group: Uses a simplified version of the app with weekly articles but no chatbot. Both groups will receive mental health screenings through the app over a 12-week period. These screenings include standard, widely used questionnaires that measure symptoms of depression and anxiety. If a participant's answers show signs of concerning symptoms, such as depression, anxiety, or thoughts of self-harm, the study team will connect her to licensed mental health professionals for support. This offers more rapid help than the current standard of care, which often screens women only once during pregnancy. The investigators hypothesize that women who interact with the chatbot version of the Moment for Parents app will complete mental health screenings twice as often as women using the app without the chatbot. In other words, the investigators believe the chatbot will increase regular screening by creating a more engaging and supportive experience. Increasing the number of completed mental health screenings could help identify emotional struggles earlier, when treatment is most effective. If this study shows that the Moment for Parents app improves screening and engagement, it could guide the design of a larger study and help shape future care for pregnant and postpartum women nationwide. Overall, this research aims to make mental health support more accessible, less stigmatizing, and easier to use.
Interventions
BEHAVIORAL
Perinatal Psychoeducation Articles
Participants access brief, evidence-based articles related to pregnancy, postpartum experiences, and infant development. Articles are designed to increase perinatal knowledge and normalize common emotional and physical changes during this period.
BEHAVIORAL
Bi-weekly Perinatal Mental Health Screening
Participants complete validated mental health screening tools (PHQ-9 and GAD-7) integrated into a mobile app. This allows screening to occur in a non-clinical, routine format and increases opportunities for early symptom identification.
BEHAVIORAL
Chatbot-Guided Journaling
Participants interact with a conversational chatbot that guides them through mood reflection prompts, journaling activities, and emotional processing exercises. The chatbot personalizes the experience using user input and delivers supportive, non-clinical language to reduce barriers to disclosure.
BEHAVIORAL
Perinatal-Focused Meditations
Participants are provided optional audio-based mindfulness and self-regulation meditations tailored to pregnancy and postpartum stressors. These meditations support emotional regulation and help participants manage worry, fatigue, and distress.
BEHAVIORAL
Themed Perinatal Learning Pathways
Participants select topic-based curricula (called "Journeys") composed of brief lessons that include educational content, reflections, and optional activities. Each pathway focuses on a specific aspect of pregnancy or postpartum well-being (e.g., resilience, social support, communication with clinicians) and prompts sustained engagement through short, sequential modules.
Primary outcome measures
Mental Health Screening Adherence
Time frame: From enrollment to 12 weeks post-enrollment
Mental health screening adherence will be measured as the total number of completed PHQ-9 and GAD-7 screenings delivered through the Moment for Parents app during the 12-week study period. Screening opportunities occur bi-weekly and are recorded passively by the application backend, allowing precise tracking of whether a participant completed each scheduled screening. Adherence will be compared across study arms using count-based analysis methods to determine whether the interactive chatbot increases screening adherence relative to the attention control condition.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Women who are:
- Pregnant or up to 1 year postpartum
- Age 18 years or older
- Lives in Michigan
- Owns a smartphone with internet access
- Proficient in English
Exclusion criteria
- Not currently pregnant or more than 1 year postpartum
- Younger than 18 years old
- Does not live in Michigan
- Does not own a smartphone with internet access
- Not proficient in English
Where
- Ann Arbor, Michigan
Collaborators
University of Michigan, National Institute of Mental Health (NIMH)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 6, 2026 · Source of record for eligibility and locations